Obe-cel was associated with lower rates of CRS and ICANS vs brexu-cel in relapsed or refractory acute lymphoblastic leukemia.
Obecabtagene autoleucel (obe-cel; Aucatzyl) was associated with lower rates of cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) compared with brexucabtagene autoleucel (brexu-cel; Tecartus) in patients with relapsed or refractory acute lymphoblastic leukemia (ALL), and the 2 CAR T-cell therapies generated comparable efficacy outcomes, according to data from an analysis of Real-World Consortium of CAR-T in Adult ALL (ROCCA) database.1
Findings from the analysis presented at the
Patients in the obe-cel cohort experienced any-grade ICANS per ASTCT criteria at rates of 17% in the overall cohort, 24% in patients with bone marrow blast levels less than 5%, and 0% in patients with bone marrow blast levels above 5%. These respective rates were 51% (P = .001), 48%, and 50% in the brexu-cel cohort. Grade 3 or higher ICANS was experienced at respective rates of 6%, 8%, and 0% across obe-cel subgroups vs 32% (P = .0027), 24%, and 43%, respectively, in the brexu-cel subgroups.
Notably, patients in the obe-cel cohort had CRS after their first and second infusions at respective rates of 31% and 46%, whereas ICANS occurred at rates of 3% and 15%.
Regarding responses, patients in the obe-cel cohort (n = 38) yielded a minimal residual disease (MRD)–negative complete response (CR)/CR with incomplete recovery (CRi) rate at day 28 of 81% compared with 80% for patients in the brexu-cel cohort (n = 54; P = 0.85). Moreover, no major differences in MRD-negative CR/CRi rates were reported between bone marrow blast subgroups. The day-28 rates of patients with active disease (obe-cel, 3%; brexu-cel, 0%), MRD-positive CR/CRi (10%; 10%), and CR/CRi with unknown MRD status (6%; 10%) were also comparable.
“Patients selected for obe-cel/brexu-cel apheresis were largely similar, noting that not all centers had access to obe-cel during the study. All patients receiving obe-cel received both doses,” lead study author Yannis K. Valtis, MD, and colleagues wrote in a poster presentation of the data. Valtis is a leukemia specialist and cellular therapist at Memorial Sloan Kettering Cancer Center in New York, New York.
Investigators of the analysis sought to discover the real-world outcomes and utilizations of obe-cel compared with brexu-cel following the
Patients were included in the analysis if they were apheresed for obe-cel after the agent’s approval, or if they were apheresed for brexu-cel after August 2024, in addition to having at least 30 days of follow-up.1
Patients included in the analysis either received both split doses of obe-cel or a single dose of brexu-cel.
The analysis’s primary end points were to evaluate the real-world patient characteristics of patients who have received obe-cel compared with patients who have received brexu-cel within a comparable period, in addition to evaluating real-world toxicities, responses, and utilization of each cohort.
Baseline characteristics revealed that patients in the obe-cel (n = 38) and brexu-cel (n = 54) cohorts had a median age at the time of infusion of 46.5 and 39 years, respectively. Patients in the obe-cel cohort had an ECOG performance status of 0 (21.1%), 1 (55.3%), 2 (13.2%), or not available (NA; 10.5%) at the time of infusion. Similarly, patients in the brexu-cel cohort had ECOG performance statuses of 0 (33.3%), 1 (31.5%), 2 (20.4%), and NA (13%) at the time of infusion. Philadelphia chromosome (Ph)–negative ALL was the most common diagnosis among patients in each cohort (44.7%; 61.1%). Ph-positive ALL was the second most common diagnosis among patients in the obe-cel cohort (23.7%), whereas it was Ph-like ALL for the brexu-cel arm (22.2%). Patients had a median of 3 prior lines of treatment in both cohorts (range, 2-4; range, 2-3). Median follow-up in the obe-cel cohort was 52 days compared with 144 days for the brexu-cel cohort.
